HEALTH & SAF E T Y
Active or passive safety devices: a useful debate?
Maria Kapoula considers the debate on active vs passive safety pen needles and discusses the question: which type of device is preferable when the full range of human factors are assessed?
In 2010, the use of safety devices for injections or infusions was mandated by European legislation to protect healthcare workers and carers from needlestick injuries (NSIs).1
Such legislation was also introduced earlier in the US in 2000, as awareness grew and the drive to protect healthcare professionals from serious or fatal infections in healthcare settings began in earnest. The market for safety products continues to grow today, with one analyst firm estimating the current global market valuation at $2,038 million, growing to $3,009 million by 2026 – registering a compound annual growth rate of 8.1% across the period.2
These safety devices have evolved into two main categories: active and passive. An active device requires the user to shield the needle after use through manual intervention. A passive device automatically shields the needle after use, with no intervention. There is a long-running debate
that discusses the merits of active safety pen needles over passive safety pen needles, typically focusing solely on the issue of safety. Although safety is undoubtedly a key issue, it is just one of many factors to be considered when selecting an appropriate drug delivery device.
The complete injection experience Mandatory human factors testing demands that manufacturers assess the ease of use of a device for all target user groups (i.e., healthcare professionals, caregivers, patients or family members), pain and discomfort during use, and patient confidence in dose delivery, among other ‘human’ criteria. These factors contribute to the whole injection experience and can significantly affect clinical objectives such as dose accuracy and therapy adherence.
Since injections may cause patients to feel anxiety, ensuring that the experience is as comfortable as possible, and that proper support is available, can encourage them to persist with their treatment. Strategies to optimise the injection experience include appropriate needle selection, patient education, behavioural interventions, and monitoring.3
Such strategies to encourage
adherence can also reduce the need for further healthcare support and interventions, ultimately reducing costs for healthcare services.
This brings us back to the debate on active and passive safety pen needles.
Based on the results of the clinical evaluation and other market research, a simple differentiation between active and passive safety devices is not sufficient since safety is not the only issue at stake.
80 l
WWW.CLINICALSERVICESJOURNAL.COM
Which type of device is preferable when the full range of human factors are assessed? As a manufacturer of both passive and active devices, Owen Mumford has a neutral, evidence-based stance on this issue. In 2020, a comparative clinical evaluation4 of an active and a passive safety pen needle device was carried out, surveying the opinions of healthcare practitioners delivering injections to patients. The results provide unbiased data for both devices, allowing readers to reach their own conclusions based on their individual clinical situation and patient requirements.
Accurate dose delivery Although passive devices have the benefit of protecting users with no action on their part, these users may also feel that they have lost some control over dosage delivery due to an increased chance of the medication administration being interrupted by premature activation of the safety mechanism. This is reflected in the results of the clinical evaluation. 98% of participating healthcare professionals (HCPs) agreed they were in control of the dose delivery when using an active safety pen needle, with comparative data for this statement on the passive device being lower at 59%. From a separate market research
exercise,5
71% of HCP participants agreed that the passive safety pen needle activates before they have finished administering the injection. 69% of these respondents went on to say that this makes them unsure of whether the full medication dose has been delivered to their patient. A large proportion of diabetes patients may already be administering inaccurate doses, reinforcing this issue relating to passive devices; the Insulin Trend report states that insulin error occurred in 40% of all people with Type 1 Diabetes and 37% of all people with Type 2 Diabetes.6
Dosage accuracy is also especially critical when the dose amount is JANUARY 2022
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72 |
Page 73 |
Page 74 |
Page 75 |
Page 76 |
Page 77 |
Page 78 |
Page 79 |
Page 80 |
Page 81 |
Page 82 |
Page 83 |
Page 84
